How Do We Control Health-Related Smartphone Apps?


First-World Problem

How Do We Control Health-Related Smartphone Apps?

Because the pancreas is buried deep in the body, pancreatic cancer is almost always fatal. Usually, it has metastasized before it is diagnosed. Now the University of Washington has developed a smartphone app that looks for pancreatic cancer using the phone’s camera and applying special formulas called algorithms. After one small clinical study, the app had nearly 90 percent success in diagnosing pancreatic cancer. More testing is necessary.

At least a start has been made here, but a great number of health-related phone apps – it is estimated that there are more than 156,000 of them – have gone un-investigated and unproven, according to Shawn Radcliffe, writing in Healthline News. The Food and Drug Administration (FDA) oversees only 200 of them, considered to have the greatest potential to do harm. “There’s the whole bottom of the pyramid – all these wellness apps. It wouldn’t be practical for the FDA to regulate them. But consumers probably need help choosing the right and the best ones to use,” says Dr. Aaron Neinstein, director of clinical informatics at the University of California San Francisco (UCSF) Center for Digital Health Innovation.

Otherwise, the vast majority of apps, from those that purport to do urinalysis to those that offer gynecological exams, are unregulated. The FDA’s decision to act is based on whether or not the app makes claims to diagnose, prevent or treat an illness. The maker can simply refrain from doing so and be free of oversight.

Apart from the FDA, the Federal Trade Commission (FTC) has acted on its own against some apps makers whose products were thought by consumers to be inaccurate and who could offer no science to back them up. States also have the potential to regulate health-related apps. New York has already acted against three companies, but both the FTC and state governments respond to complaints rather than initiate oversight.

The apps stores, chiefly Apple iTunes and Google Play, do nothing to police the products they sell. “The apps stores weren’t in any way designed for the challenges of health-related claims. And it’s not reasonable to expect them to be so, either,” says Henry Mahncke, Ph.D., chief executive officer of Posit Science, which produces the brain training software and app BrainHQ.

The consumer is dependent on the integrity and seriousness of the app maker. There is really no way to be sure of the accuracy and reliability of any app. UCSF’s Neinstein cautions people to ask themselves, “Is there the potential for risk with the type of app I’m choosing? Or is this pretty harm-free?”

For example, an inaccurate step-counter may merely be a waste of money while an app used to determine insulin dosage “could be potentially life-threatening,” says Neinstein.

Scientifically sound and vauable health-related apps may be out there, but as Posit Science’s Mahncke puts it, they may be “lost in the tidal wave of nonsense found in the app store.”

So consumers are on their own and must protect themselves. The more serious the health issue is, the more cautious we should be about an app that is meant to address it.

It comes down to the ancient phrase, “caveat emptor” – let the buyer beware.



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